World's first dual therapy stent launched

HONG KONG – OrbusNeich launched the world's first dual therapy stent -- the COMBO Dual Therapy Stent -- to address the challenges of delayed healing of the coronary artery associated with monotherapy drug eluting stents (DES), the current standard of care for the treatment of coronary artery disease (CAD). The introduction is in conjunction with the company's receipt of a CE Mark for the product and involves a sales roll-out in Europe and selected markets in the Asia Pacific and Middle East regions.

The COMBO Dual Therapy Stent is the first stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of OrbusNeich's proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

"The COMBO Dual Therapy Stent is the next wave of drug eluting stent technology," said Al Novak, OrbusNeich chairman and CEO. "The dual therapy approach maintains the efficacy of monotherapy drug eluting stents while providing the benefits of accelerated stent endothelialization and healing. At OrbusNeich, we believe that minimizing restenosis in the near term and maximizing healing in the long term are of equal importance. Interventional cardiologists now have a no-compromise solution that offers both. With CE Mark approval, the COMBO Dual Therapy Stent has set a new, rigorous standard for stent innovation."

Roxana Mehran, M.D., Mount Sinai Medical Center, said, "I believe that COMBO is the next-next-generation drug eluting stent, combining the anti-restenotic property of drug eluting stents with endothelial progenitor cell (EPC) capture, which is able to heal the surface of the stent. We're most excited about the possibility of actually having a stent for which you do not need prolonged dual antiplatelet therapy (DAPT), and I think that is the future. Obligatory, prolonged DAPT is no longer going to be the standard -- we cannot accept that anymore. And so, we're looking for a safer stent, and I think this very unique and interesting platform has incredible promise."

Nine-month clinical outcomes from the REMEDEE study confirmed that the COMBO Stent is as effective as a monotherapy DES, with respect to in-stent late lumen loss at nine-month angiographic follow-up. These data were used to support CE Mark approval for COMBO.

"Late stent thrombosis is still a concern for patients treated with monotherapy DES, leaving them dependent on a minimum of six months DAPT," said Michael Haude, M.D., director of Medical Clinic I at the Lukaskrankenhaus in NeuAir Jordan XIII 13 Kid